Medication guide symptoms and conditions

Consumer Medication Information (CMI) distributed by pharmacies with prescriptions is NOT regulated by the FDA and may not contain a complete list of side effects from the medication's FDA approved label.

CMI is usually stapled to the prescription bag or inside it and is often produced by private companies that provide this information to pharmacies. It is different than a medication guide or patient package insert, which are FDA approved, published by drug manufacturers, and and required to be distributed with certain medications.

You can get accurate medication side effect information from the United States National Library of Medicine's DailyMed website.

Saw this story on CNN today. Guess we aren't all tinfoil-hat wearing nutcases after all.

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FDA orders 'black box' label on some antibiotics

The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendinitis.
Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

Cipro is one of the drugs for which the FDA will require a "black box" label warning about tendon problems.

"The new language will strengthen the existing warnings," said Dr. Edward Cox, director of the FDA's Office of Antimicrobial Products.

The FDA is requiring the label warnings and a medication guide for fluoroquinolone drugs, which include Cipro, Levaquin, Avelox, Noroxin and Floxin.

The consumer group Public Citizen asked the FDA in August 2006 to put the "black box" warning on Cipro and other fluoroquinolones, and also to warn doctors. Earlier this year, Public Citizen filed a lawsuit to force the FDA to take those actions.

When asked about the lawsuit and why it took so long to add the label warning, Cox stressed that the FDA included warning information with the drugs from 2001 until 2004, and updated the information last year.

"There has been ongoing work to update the labeling of the fluoroquinolone drug products," Cox said. "We have been working on this issue and making progress over time."

The companies that make the fluoroquinolone drugs will be required to submit label safety changes and the medication guide within 30 days of receiving the notification from the FDA or provide a reason why they do not believe such labeling changes are necessary, Cox said.

The fluoroquinolones drugs can increase the risk of tendinitis and tendon rupture -- which is about 1 in 100,000 -- by three to four times, according to the FDA's Dr. Renata Albrecht.

"This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy," the FDA said in a statement.

Albrecht said that sometimes patients have no symptoms before they experience a rupture in their tendon -- commonly their Achilles tendon.

"Sometimes it's been reported on the first day of taking a fluoroquinolone ... a sudden snap or popping sound that is tendon rupture with no preceding warning," she said.

Normally, she added, that patients experience some pain or inflammation "a week or two before the patient will rupture."

The FDA would only say that it has received "hundreds" of reports of tendon problems linked to fluoroquinolones, without being more specific, citing the ongoing lawsuit. But Cox said "the FDA continues to receive a considerable number of reports on tendon adverse effects."

Patients should stop taking fluoroquinolone antibiotics at the first sign of tendon pain, avoid exercise and contact their doctor, the FDA said.

Cox said the FDA would not require companies to send letters to doctors alerting them about the connection between tendon problems and the antibiotics.

"It is possible under REMS to ask for a letter ," Cox said. "Certainly for sponsors that would choose to go forward with a letter, we'll be happy to work with them."

I had been taking Advair 500/50 for several years, however, most of that time I only took it once a day (not the recommended 2X). My diagnosis is near fatal asthma/COPD. About a year and a half ago I began taking Spiriva in addition. I am stable, but with a low pulmonary function for the past year (peak flow remains around 200). I see an acupuncturist/herbalist and an currently trying Wei Labs products: Soup A and LC Balancer, that are supposed to reverse lung damage. I recently visited a new, conventional, pulmonary specialist who wanted me to retry Advair at its recommended dosage, which I did. I noticed a nagging headache (at my forehead), a tendency to be agitated very easily, and a diminished peak flow. His response was to continue and add another medication (Singulair, which I have tried years ago with no good result). I stopped the Advair (though I am continuing on the Spiriva, until I see more results from the herbs). Also, I am a thin person who exercises all the time, and I had noticed that my weight was about 10 lbs more than I would like it to be (this had been the case for a couple of years). I have yet to see if that will drop, I have only been off for a couple of days. Additionally, I have had the experience with conventional steroid sinus meds over the years; the meds would stop working after a month or two and I would end up with worse congestion. I ultimately had a surgery to clear polyps and extra tissue, and have been breathing well through my nose since 2004 without meds. I feel I need to get off the conventional meds for the asthma too, on them I appear to be in a slow decline.

My son came down with pneumonia about two years ago. After being hospitalized for his pneumonia for five days(his oxygen was at 83 percent), he was put on Albuterol and Pulmicort for about a year which was working ok till his wheezing started to get worse .His doctor said it was time to see a asthma specialist in Forth Worth, Texas named Dr. Rogers. Well, Dr. Rogers evaluated my son and took an xray of his nose, diagnosed him with sinusitis and with severe asthma . MY son was put on Advair 115/21 immediately and told to get off all other medicine including his Pulmicort. He was to use the Advair two puffs twice daily every day . HE was to use the Albuterol when he was coughing or needed it for rescue. I got the Advair and as a cautious parent , I always read all of the medication guide that comes with the medication I give my son . I read all the side effects and became at that very night I was to give the medication to him very scared but I was told by Dr. Adams that it would control his asthma. The next day I tried to get in touch with my doctor but was talked to by his nurse and assured the medication was safe. My son at the time also had an upper sinus infection and was put on Prednisone and Zyrtec for his allergies, Nasonex, and also Omnicef which is an antibiotic for 20 days.
Even one day after taking the medicine, my son was sleeping and started sweating really bad that night and he had tremors in his legs and his arms and his heart was racing . As I watched my son sleep even on that second night of taking Advair, I put my head to his chest and would listen to his heartbeat cause now I was worried . His heartbeat was regular at first then when I listened more his heartbeat actually would skip a beat every now and then and his body would shake when it started to beat normal again .
I called the doctor two days after he was on the medicine and he assured me it was the Prednisone my son was on and not the Advair and I told the doctor about the tremors and he also said it was the other medicine . Then I asked the doctor about all the information in the medicine guide that came with the medicine that was conducted in 2006 a few years ago and all the side affects and all he said was that Advair was the safest on the market at this time and that the study in the report was a horribly conducted study and that usually people were dying not cause of the Advair but the Salmeterol being used alone and not a bronchioldialator used to treat both symptoms . It has been four weeks, one month since my son has been using Advair and he is off the other medications he was taking for his sinus infection. These are his symptoms after he takes the medication. About one hour after he take his medication he is very hyper, nervous, his heart is racing a mile a minute without even running around, he is sweating, he can not sit still for one minute and he has muscle spasms. At night when he goes to sleep his whole body shakes as though in a convulsion and I have even had to be there with him to calm him down. He has bad leg shakes and his arms shake and every single night since he has taken this medication he has sweated so badly that it soaks the pillow through and the pillowcase down to the mattress. He had been running fevers at night for five nights now . I was told this medication was safe but when I look at my son his eyes are glassy all the time and he is just not the same and he does not seem happy with all these tremors he has with this medicine . If anyone is reading this please print these pages out and take to a lawyer so we can all get money from the makers of Advair because I'm sure like me we were all told this medication was safe and not harmful . I am calling my sons asthma specialist and telling him to take him off this medication immediately as I had requested before and he told me it wasn't wise because it was controlling his asthma . How can a medication control asthma symptoms that will cause a person to die from taking it and cause them worse symptoms when they try to get off of it?